Biological And Chemical Analysis Of Diagnostic Reagents In The Application Of The Construction Standards

Objective Because myocardial injury and cervical cancer for people growing threat to health, so for cardiac troponinⅠ(Cardiac troponinⅠ, cTnⅠ) and human papillomavirus (Human Papiliomavirus, HPV) study more and more people pay attention to. Cardiac TroponinⅠis composed of cardiac troponin subunit complexes, one has been identified as clinically determined diagnosis of myocardial injury markers. HPV is an outer ring do not have double-stranded DNA structure of the virus. Clinical diagnosis of cervical cancer is as important indicators. Currently, there are many domestic and HPV for the detection of cTnⅠand related products, but our country there is no national standard for cTnⅠand HPV typing of whole genome its national system of quality control materials to assess. The purpose of this study on cTnⅠstandard and whole-genome genotyping of HPV DNA control samples of the preparation, analysis, identification and application of research to the relevant national standards for future development of material basis. Method Using matrix-assisted laser desorption ionization/time of flight mass spectrometry (MALDI-TOF-MS), liquid chromatography-mass spectrometry (Q-TOF-MS and LC-ITMS), ELFA (Enzyme-linked fluorescence analysis) method, solid phase, sandwich Chemistry luminescence immunoassay, molecular biology methods (PCR-hybridization) and sequencing by capillary electrophoresis (CAE), method of surface plasmon resonance (SPR) and other methods of cTnⅠstandard and whole-genome genotyping of HPV DNA control samples were prepared and analysis. And use the preparation of whole-genome genotyping of HPV DNA control samples of the related products were evaluated. Result Completed the preparation for the standard cTnⅠ, characterization and assignment work. Completed a whole genome DNA HPV genotyping quality control and verification of products developed and carried out its application, and achieved good results.